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The old-fashioned autocratic manager who ruled with an iron hand and controlled everything from the top has pretty much vanished from the management scene. Not many regret his passing. There is n

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

o doubt that today's enterprises operate far more humanely than did their old school predecessors, at least on the surface.

Although "Theory X" management has been replaced in virtually all sect

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ors, successor approaches have their own weaknesses. This brief article is intended to raise two ideas for your thoughtful consideration. The first is that distinctions exist between participator

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

y management and consensus management. The second is that important consequences flow from those distinctions.

Participatory management and consensus management practitioners both understand tha

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

t employees have perspectives that are potentially valuable to the decision-making process and that "buy in" plays a vital motivational role with real consequences for performance. Beyond this in

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

itial point of agreement, distinctions emerge. To put the matter in perspective, consider the extent to which you agree or disagree with each of the following assumption statements.

Obta

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ining agreement among stakeholders should be the controlling consideration when reaching a decision that affects the organization, regardless of the issue.

All ideas have equal merit.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

li>

Everyone's contribution should be given equal weight in the decision process, regardless of expertise or responsibilities.

The best interest of the organization is always equal

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

to the sum of the best interests of its departments and stakeholders.

Participatory managers recognize a foundational management principle; i.e., authority can be delegated but

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

responsibility cannot. Participatory managers seek input from all whose views can benefit the process. However, final decision-making is reserved to those who ultimately bear the responsibility f

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

or the decision.

Consensus managers, on the other hand, start with the proposition that agreement among stakeholders must be obtained before action proceeds, a position that is intellectually de

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

fensible only if one believes all of the bulleted assumptions listed above to be true. Now consider the consequences of those assumptions.

Decision-making becomes a political process ins

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

tead of a merit-based process with the pace and outcome controlled by the least flexible and most obdurate participants.

Consensus management is inherently biased toward inaction. All t

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

hat is necessary to block any action is to prevent consensus. Self-evidently, this characteristic is not conducive to success in a competitive environment defined by fast-paced change.

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Decision quality is degraded, at least from a business perspective. That is because the goal becomes identifying a solution that is the least offensive to all stakeholders rather than choosing th

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e course of action that is most beneficial to the enterprise.

An inevitable consequence of using consensus as a surrogate for the executive function in an organization designed to opera

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

te as a hierarchy is a diminution of the very concept of accountability. When everyone is responsible, no one is accountable.

This is not to say that consensus management is never

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

a good idea. In an organization of true peers, all of whom share a common skill set, the same organizational perspective, and an identical stake in the decision outcome, it may well work. That de

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

scription, however, does not apply to the typical management team.

It has been our observation that consensus decision-making is strongly associated with the presence of information silos and or

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ganizational gridlock. All executives and managers would be well advised to consider how the current choice of decision-making models is affecting the quality and timeliness of management action.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Proceeds from the sale of your business represent your return on years of hard work and may also provide a significant portion of your retirement income. Knowing how your business will be valued and knowing how to calculate a rough valuation is your first step in preparing for your future.

I have developed a definition of corporate culture after nearly 20 years of working with organizations and viewing them from the perspective of a cultural anthropologist as well as a strategy consultant with an MBA in finance.

So you've figured out, more or less what you want to do and where the opportunities are. Now; you have been called for an interview. Here are five steps for interview success for students and graduates.

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